A Randomised Controlled Trial on the Autonomic and Cardiovascular Effects of Indian Classical Music on Young Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
This is a randomised, double- blinded, parallel group, single centre study to know the effect of Indian classical music ( Raga Puriya) on cardiac autonomic functioning of healthy human volunteers.The parameters studied are Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability.After the baseline assessment, each participant will be randomized either into the experimental group or the control group using block randomization technique. A Ten-minute, pre-recorded instrumental rendition of raga Puriya will be played via headphones connected to a laptop, at a uniform volume (50%) to the experimental group.In the control group ,natural sounds (birds chirping and flowing river) will be played for 10 seconds duration once every 2 min. The Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability will be recorded during and post music interventions and compared between two groups using T test and ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals of age 20-30 years of either gender medically and surgically healthy give consent to participate in the study.
排除标准
- •Smokers Alcoholics.
- •Hypertensives Participants on any medication known to affect the BP or autonomic status of the individual.
- •Pregnancy Body mass index (BMI) more than 30 kg/m2.
结局指标
主要结局
Systolic Blood Pressure
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
Diastolic Blood Pressure
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
Pulse Pressure
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
Mean Arterial Blood Pressure
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
Heart Rate
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
Heart Rate Variability
时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline
次要结局
未报告次要终点
研究者
Sreelakshmi K
Department of Physiology, Pushpagiri Institute of Medical Sciences and Research Centre
